iExaminer

By Brian Dolan 06:54 am August 1, 2014

Kinsa's smartphone-connected thermometer The US Food and Drug Administration has proposed to largely deregulate a sizable list of Class II and Class I medical devices and no longer require their makers to go through the 510(k) process. The agency made clear the deregulatory move would not necessarily exempt the device makers from other steps like appropriately registering and labeling their...

FDA clears Welch Allyn's iPhone-enabled opthalmoscope

By Jonah Comstock 01:52 am January 24, 2013

An iPhone app and peripheral device that allows doctors to use the iPhone camera to take photographs of the interior surface of the eye has received 510(K) FDA clearance. The iExaminer System from Welch Allyn will build on the company's existing PanOptic Opthalmoscope, a device that lets a physician see into the back of a patient's eye. The FDA clearance is for an adapter that connects the...